tbuckley/cabot-search huggingface dataset:
Barriers and facilitators to enrolling in a cancer clinical trial financial reimbursement program.
Authors: Vivian Nguyen, Elizabeth Ramos, Dana Dornsife, Robert G. Johnson, Erin Miller, Mallorie Jones, Daniela Uribe, E. Paul Wileyto, Robert H. Vonderheide, Carmen Guerra
Journal: Journal of Clinical Oncology (2023)

e18641 Background: Cancer clinical trial (CCT) participants often have significant out-of-pocket expenses. These expenses may disproportionately burden lower income participants. To increase access to CCTs, the Lazarex Cancer Foundation (LCF) created the Improving Patient Access to Cancer Clinical Trials (IMPACT) Program, a financial reimbursement program for out-of-pocket travel and lodging expenses. This study was designed to evaluate the barriers and facilitators to enrolling and participating in the IMPACT Program. Methods: This qualitative study consisted of semi-structured interviews with a subset of CCT participants at the Abramson Cancer Center (ACC) of the University of Pennsylvania who enrolled in the IMPACT Program and consented to this study. The interview focused on barriers and facilitators of enrolling in the program and suggestions for improving enrollment. The interviews were analyzed using grounded theory methods of analysis. Results: From May 2021 to January 2023, 75 patients enrolled in the program and 31 patients participated in the interview (57% Female, 93% White, Median Age (SD) = 66.0 years (13.6)). The most common cancers represented in this population were hematological, gastrointestinal, and breast cancers (37.3%, 16.0%, and 13.3%, respectively). The table shows the reported barriers and facilitators of enrolling in IMPACT. The most commonly cited barriers were related to the process of enrollment (participants wished to be contacted earlier before accruing expenses) and patient barriers (technology access and privacy concerns). The most common facilitator to enrollment was receiving assistance and explanation from ACC IMPACT coordinators. Participant suggestions for improving enrollment in IMPACT include earlier introduction of the program to potential clinical trial participants during the informed consent process and offering navigation services for cancer center resources. Conclusions: Out-of-pocket expenses related to clinical trials can be addressed through financial reimbursement programs. To optimize the benefit of these programs, it is ideal to enroll patients at the time of informed consent, establish IMPACT coordinators, and use technology to streamline the enrollment and submission process. [Table: see text]
Impact of COVID-19 pandemic on lung cancer diagnosis in a community hospital.
Authors: Sumukh Arun Kumar, Abinesh Sekar, Abhishek Singh, Sharmitha Ravichandran, Rahul Mishra, Ahmad Daniyal Siddiqui
Journal: Journal of Clinical Oncology (2023)

e18634 Background: Coronavirus disease 2019 (COVID 19) pandemic saw its first case in the United States in 2020. Although lung imaging for COVID-19 patients theoretically increased chances of detecting cancerous lung nodules, strict quarantine measures disrupting routine cancer screening was a concern. Real-world data on lung cancer diagnosis during the pandemic at community level is less known. Methods: We conducted a retrospective chart review on patients newly diagnosed of lung cancer from 2018- 2022 in our community hospital. Demographic details, year of diagnosis, type and stage of cancer, inpatient or outpatient diagnosis and mode of diagnosis (surveillance, incidental or symptomatic) was noted. Descriptive analysis of the above parameters was conducted across three eras- 2018 and 2019 as pre-COVID era (PreCo), 2020 and 2021 as COVID era (Cov) and 2022 as post-COVID era (PosCo) irrespective of COVID-19 diagnosis. Results: Out of 287 patients included, 40% (116) were diagnosed during PreCo, 27.5% (79) during Cov and 32% (92) during PosCo. In the PreCo, 16% (19) were incidentally detected, 21% (24) were ISym, 48% (56) on surveillance, and 15% (17) were OSym. In Cov, 13.9% (11) were incidentally detected, 53.3% (42) were ISym 13.9% (11) on surveillance, and 18.9% (15) were OSym. In PosCo, 11.3% (11) were incidentally detected, 19% (18) were ISym, 44% (41) on surveillance, and 24% (22) were OSym. Stage IV cancers among new lung cancer diagnoses were noted to be highest in PosCo (43.4%) followed by PreCo (31.9%) and Cov (26.6%). Conclusions: Cov saw a decrease in the annual rate of new lung cancer diagnosis compared to PreCo likely secondary to reduced routine screening. A staggering increase in new and stage IV cancers were noted in PosCo which could stem from missed screening as well as rapid progression of undiagnosed cancers during the pandemic. In Cov, there was a dramatic increase in symptomatic inpatient lung cancer cases (53.3%) as symptoms of COVID-19 and lung cancer overlap. Comparable rates of cancer diagnosis via surveillance in PosCo (44%) and PreCo (48%) hints at possible restoration of access to outpatient cancer care. [Table: see text]
Hospitalization for immune related toxicity and overall survival (OS) among patients with metastatic non-small cell lung cancer (NSCLC) treated with first-line pembrolizumab.
Authors: Adam Khorasanchi, Songzhu Zhao, Lai Wei, Mingjia Li, Kevin Ho, Hamzah Abu-Sbeih, John Howard Alexander, Evelyn Goodyear, Austin Secor, Peter G. Shields, Kai He, Jacob Kaufman, Regan Michelle Memmott, Asrar Alahmadi, David Paul Carbone, Gregory Alan Otterson, Alexa Simon Meara, Carolyn J Presley, Dwight Hall Owen
Journal: Journal of Clinical Oncology (2023)

e21215 Background: Few studies have investigated the association between patients with NSCLC hospitalized due to complications of ICI and subsequent OS. Immune related adverse events (irAEs) are autoimmune syndromes, side effects of ICIs. We evaluated the rates of irAEs among patients with metastatic NSCLC hospitalized within 1 year of pembrolizumab treatment and OS. Methods: This retrospective study included 102 patients (out of 411 total patients screened) with Stage IV NSCLC treated with a first-line pembrolizumab regimen (alone or in combination with chemotherapy) at the Ohio State University from 2018-2022 who developed an irAE. A chart review was completed for patient demographics, unplanned hospitalizations (irAE or any reason) within 1 year of ICI, and type of irAEs leading to hospitalization. Descriptive statistics were summarized and compared by irAE hospitalizations (Yes vs No) or any reason hospitalizations (Yes vs No). Kaplan-Meier survival analysis and log-rank test were used to assess the associations between these two groups with OS. Results: Twenty-one percent (21/102) of patients were hospitalized for irAE within 1 year, for the following irAE types: 7 pneumonitis (33.3%), 6 colitis (28.6%), 2 dermatitis (9.5%), 1 hepatitis (4.8%), 1 myalgia (4.8%), 1 neurological (4.8%), and 1 hypophysitis (4.8%). 68 were hospitalized for any reason including irAE, infections, cancer progression, and pain. Patients age, gender, race, and body mass composition were similar between two groups. Patients with irAE hospitalization had shorter OS (13.8 m, 95% CI 2.73-NR) than those without irAE hospitalization (53.6 m, 95% CI 33.18-NR, p = 0.0105). Hospitalization irAE rates were not significantly different between pembrolizumab alone and pembrolizumab-chemotherapy, however overall hospitalization rate was higher in pembrolizumab-chemotherapy (77%) than pembrolizumab alone (55%), p = 0.0214. Conclusions: This study suggests patients who are hospitalized following ICI treatment may have worse outcomes. Hospitalization rates overall were higher for patients treated with pembrolizumab-chemotherapy than pembrolizumab alone. Further investigation is needed to confirm these findings as our study was limited to patients who experienced irAEs during treatment.
A phase 2 study of alrizomadlin (APG-115) in combination with pembrolizumab in patients with unresectable or metastatic cutaneous melanoma that has failed immuno-oncologic (IO) drugs.
Authors: Montaser F. Shaheen, Jennifer Margaret Segar, Bartosz Chmielowski, Joseph J. Drabick, Meredith McKean, James A. Reeves, Christos Stelios Karapetis, Marlana M. Orloff, Anthony W. Tolcher, J. Thaddeus Thaddeus Beck, Brian Gastman, Asit De, Ben Paudyal, Robert E Winkler, Mingyu Li, Mohammad Ahmad, Dajun Yang, Yifan Zhai
Journal: Journal of Clinical Oncology (2023)

9559 Background: Alrizomadlin is a novel, orally active small-molecule MDM2 inhibitor that activates p53-mediated apoptosis in tumor cells, also functions as a host immunomodulator, and may restore antitumor activity in patients with cancer that has progressed on PD-1/PD-L1 inhibitors. Alrizomadlin is currently being investigated for treatment of patients with unresectable or metastatic cutaneous melanoma that progressed on prior immunotherapy. Methods: This multicenter clinical trial was conducted in the United States and Australia in patients with unresectable or metastatic cutaneous melanoma that had progressed on PD-1/PD-L1 immunotherapy. Eligible patients had an ECOG performance status of 0-2. Alrizomadlin 150 mg was administered orally every other day for 2 consecutive weeks, with 1 week off, and pembrolizumab 200 mg intravenously for 30 minutes on Day 1 of a 21-day cycle. Results: As of December 12, 2022, preliminary and interim results are reported for 31 patients with cutaneous melanoma, of whom 21 were male and 10 female, with a median (range) age of 65 (27-84) years. Treatment-related adverse events (TRAE) of any grade ( &gt; 10%) for either alrizomadlin or pembrolizumab were reported in 30/31 (96.8%) patients. These AEs included nausea (71%), vomiting (38.7%), fatigue (35.5%), thrombocytopenia (32.3%), diarrhea (25.8%), neutropenia (19.4%), decreased appetite (16.1%), and decreased leukocyte count (12.9%). A total of 4/31 (12.9%) patients reported treatment-related serious AEs, including anemia, thrombocytopenia, deep vein thrombosis, joint effusion, pulmonary embolism, and vomiting. In 26 efficacy-evaluable patients, the confirmed overall response rate (ORR; partial response [PR] + complete response [CR]) was 23.1%, including 2 patients reporting CRs and 4 reporting PRs based on RECIST v.1.1. The initial analysis indicated that the ORR observed in patients whose disease had failed IO treatment was primarily due to alrizomadlin combined with pembrolizumab, not the delayed effect of prior immunotherapy. Conclusions: Alrizomadlin combined with pembrolizumab is well tolerated and demonstrates clinical efficacy in these patients with highly refractory unresectable or metastatic cutaneous melanoma that had progressed on PD-1/PD-L1 immunotherapy. Internal study identifier: APG-115-US002. Clinical trial information: NCT03611868 .
Analysis of delivery of cancer survivorship education to community healthcare professionals.
Authors: Ashley Pariser, Kevin Nathaniel Johns, Dena Champion, Andrea Roberts, Susan Fugett, Erin Holley, Candice Schreiber, Karen Hock, Jalyn Todd, Andrew Honeychuck, Katherine Hunt, Yurong Lu, Bhuvaneswari Ramaswamy, Seuli Bose Brill
Journal: Journal of Clinical Oncology (2023)

12136 Background: There are currently 18.1 million cancer survivors in the United States; anticipated to reach 26.0 million survivors by 2040. Educational opportunities for healthcare providers in survivorship care is needed to insure capacity for this rapidly growing population particularly in the community setting. This pilot study implemented a cancer survivorship Project ECHO model in two community hospitals within a larger community health system. Methods: Providers affiliated with the Mercy Health System were enrolled in one of two cohorts. Eligible participants included physicians, advanced practice providers, nurses, social workers, and dietitians. Six one-hour sessions were developed from a needs assessment and delivered over a 12-week period. Participants were invited to complete pre and post session surveys to evaluate the following 3 domains: professional improvement (PI), self-efficacy (SE), and knowledge (KN). A Likert scale was used with each survey item rated 1-5, where 1 represents lowest and 5 highest (agreement/confidence/knowledge). The average score for survey items within each domain was utilized to compare pre- and post-survey results. Results: Fourteen multidisciplinary providers were enrolled in both Cohort 1 and Cohort 2. Twenty-six completed the baseline survey and 22 completed the post-study survey. The mean change of each domain (PI, SE, KN) and mean overall change are summarized in the table. For cohort 1, the overall score significantly increased 0.94 (0.45,1.42) (P=0.0023). While the SE and KN domain scores increased significantly (1.1 (0.5,1.7), 1.03 (0.45,1.62) and p = 0.003, 0.0036, respectively), the PI did not change -0.09(p=0.726). For cohort 2, the overall score significantly increased 0.617 (0.042,1.193) (P=0.0378). While the SE and KN domain increased significantly (0.728(0.048,1.407), 0.665 (0.041,1.289) and p = 0.0379, 0.0387, respectively), the PI did not change (p=&gt; 0.999). Conclusions: The Cancer Survivorship ECHO model may serve as a scalable strategy for building cancer survivorship care capacity in community-based oncology practices through equipping multidisciplinary teams to meet the needs of cancer survivors within their community. Further research is needed to assess implementation of this model into novel settings and evaluate its impact on patient outcomes. [Table: see text]
Incidence of additional primary malignancies in patients with malignant peritoneal mesothelioma.
Authors: Vivek Pandav, Jaydeepbhai Patel, Jyothik Varun Inampudi, Shenduo Li, Himil Mahadevia, Hiren Koshiya, Yanyan Lou, Rami Manochakian, Sanjay Prakash Bagaria, Yujie Zhao
Journal: Journal of Clinical Oncology (2023)

e20535 Background: Malignant peritoneal mesothelioma (MPM) is a rare disease with about 600 new cases per million people diagnosed annually in the U.S. High incidence of germline mutations has been reported in MPM patients (pts) without asbestos exposure. However, the incidence rate of developing multiple primary cancers in this population is unknown. The aim of this study is to investigate the frequency of additional malignancies in MPM pts. Methods: Using the Mayo Clinic Cancer Registry, we identified 64 pts who were treated for MPM from January 2002-December 2022 with updated follow-up data until 01/15/2023. Electronic medical records were reviewed. Results: Among the patient cohort, 25 pts were male, and 39 pts were female. 14/64 (22%) pts were found to have at least one additional malignancy, including breast cancer (4/14, 29%), colon cancer (3/14, 21%), lymphoma (3/14, 21%), ovarian cancer (2/14, 14%), melanoma (2/14, 14%), anal squamous cell carcinoma (1/14, 7%), papillary thyroid cancer (1/14, 7%), Chronic lymphocytic leukemia (1/14, 7%), renal cell carcinoma (1/14, 7%), squamous cell carcinoma of tongue (1/14, 7%), hepatocellular carcinoma (1/14, 7%) and pituitary macroadenoma (1/14, 7%). 4/14 (29%) pts had more than one (2-4) non-MPM malignancies. The median age at diagnosis of MPM was 65 years (44-82). The median age at diagnosis of non-MPM malignancies was 66 years (18-81). Most of the patients (11/14) were diagnosed with non-MPM malignancy within 12 months of diagnosis of MPM. Most pts (11/14, 78%) were diagnosed with non-MPM malignancy first, among which 5 pts (45%) were found to have MPM on surveillance scans. Germline mutation information was not available except for 2 pts with known family history (FH) of Lynch syndrome and Li-Fraumeni syndrome. FH was available in 29 pts, out of which 28 pts had FH of cancer identified in first-degree relatives. Among the 14 pts with additional malignancies, 9 pts had FH of cancer in first-degree relatives. Among all pts, 15 (18%) pts had a history of asbestos exposure. Among pts who also had non-MPM malignancies, 3/14 (21%) pts had a history of asbestos exposure. Among the 21 non-MPM cancers, 1/21 (5%), 11/21(52%), 1/21(5%), 3/21(14%), and 5/21(24%) non-MPM malignancies were stage 0, stage I, II, and III, or unknown at the diagnosis respectively. All except 1 pt underwent curative treatment for their non-MPM malignancies, and 12 pts had no evidence of disease at death or the time of last follow-up. Conclusions: The rate of multiple primary malignancies in pts with MPM is high, indicating possible genetic predisposition associated with this disease. Early genetic consultation and evaluation for germline mutations may need to be considered for these pts to improve long-term outcomes.
Early detection of lung cancer using a panel of circulating cell-free DNA methylation biomarkers.
Authors: Shuo Hu, Jinsheng Tao, Minhua Peng, Bo Wang, Zhujia Ye, Zhiwei Chen, Haisheng Chen, Haifeng Yu, Jianbing Fan, Bin Ni
Journal: Journal of Clinical Oncology (2023)

e20614 Background: Lung cancer remains the leading cause of cancer mortality worldwide. Early detection of lung cancer helps improve treatment and survival. Numerous aberrant DNA methylations have been reported in early-stage lung cancer. Here, we sought to identify novel DNA methylation biomarkers that could potentially be used for noninvasive early diagnosis of lung cancers. Methods: This prospective-specimen collection and retrospective-blinded-evaluation trial enrolled a total of 317 participants (198 tissues and 119 plasmas) comprising healthy controls, patients with lung cancer and benign disease from The First Affiliated Hospital of Soochow University between January 2020 and December 2021. Tissue and plasma samples were subjected to targeted bisulfite sequencing with a lung cancer specific panel targeting 9,307 differential methylation regions (DMRs). DMRs associated with lung cancer were identified by comparing the methylation profiles of tissue samples from patients with lung cancer and benign disease. Markers were selected with minimum redundancy and maximum relevance (mRMR) algorithm. A prediction model for lung cancer diagnosis was built through logistic regression algorithm and validated independently in tissue samples. Furthermore, the performance of this developed model was evaluated in a set of plasma cell-free DNA (cfDNA) samples. Results: We identified 7 DMRs corresponding to 7 differentially methylated genes (DMRs, including HOXB4, HOXA7, HOXD8, ITGA4, ZNF808, PTGER4, and B3GNTL1), highly associated with lung cancer by comparing the methylation profiles of lung cancer and benign nodule tissues. Based on the 7-DMR biomarker panel, we developed a new diagnostic model in tissue samples, termed “7-DMR model”, to distinguish lung cancers from benign diseases, achieving AUCs of 0.966 (95%CI: 0.933-1.000)/0.961 (0.924-1.000), sensitivities of 0.887 (0.824-0.951)/0.922 (0.863-0.980), specificities of 0.938 (0.889-0.986)/1.000 (1.000-1.000), and accuracies of 0.896 (0.835-0.957)/0.938 (0.886-0.991) in the discovery cohort (n = 96) and the independent validation cohort (n = 81), respectively. Furthermore, the 7-DMR model was applied to noninvasive discrimination of lung cancers and non-lung cancers including benign lung diseases and healthy controls in an independent validation cohort of plasma samples (n = 106), yielding an AUC of 0.935 (0.862-1.000), sensitivity of 0.808 (0.733-0.883), specificity of 0.975 (0.945-1.000), and accuracy of 0.934 (0.887-0.981). Conclusions: The 7 novel DMRs could be promising methylation biomarkers that merits further development as a noninvasive test for early detection of lung cancer.
A novel program to address acute food insecurity among patients with cancer in Philadelphia.
Authors: Michael Rowe, Gina Mancuso, William Kevin Kelly, Greg D. Garber, Elliott Sina, Amy Leader
Journal: Journal of Clinical Oncology (2023)

e18739 Background: Acute food insecurity (FI) is a significant yet poorly understood social risk factor facing cancer patients, with a prevalence greater than that of the general U.S. population. FI poses a particular risk for cancer patients, as FI-induced malnutrition is associated with fatigue, stress, depression, and a weakened immunological response to infection. Legacy of Hope is a non-profit organization based in Philadelphia, PA providing emergency support to cancer patients in financial distress. Partnering with local grocery stores to supply the food and local police districts to deliver the groceries, Legacy of Hope receives patient referrals from social workers at cancer centers in Philadelphia to identify patients and families in need. Cancer patients can receive one or more bi-weekly grocery deliveries until their acute FI needs are addressed. Legacy of Hope documents and tracks metrics associated with the patients who are served by the program. Beginning in 2023 is direct participant evaluation of the program, assessing outcomes in acute anxiety, quality of life, and acute FI. Methods: Legacy of Hope receives ongoing referrals from oncology social workers about cancer patients in need. Legacy of Hope documents the cancer diagnosis, age, race/ethnicity, and gender of the cancer patient as well as the size of the household and the number of children living in the house. Additionally, a participant evaluation survey collects data via an online survey at two time points: first, at the time of their grocery delivery and second, two weeks after the delivery. The survey uses validated measures (FACT-G7) to assess changes in quality of life and anxiety, as well as acute FI, over the two-week time period. Standard statistics, including a paired t-test, will evaluate the changes in the outcome measures of interest. Results: Legacy of Hope has served more than 1600 cancer patients representing more than 2000 food deliveries. About half (52.2%) were female and 58% were African American. The mean age was 60 years old. Breast cancer was the most common diagnosis (18%), followed by lung (8%) and colorectal cancer (5%), although almost all cancers are represented in the database. One in five patients (21%) lived alone, but most (45%) had between 2 and 3 persons in their household. Children were present in the home 21% of the time. Data for the participant evaluation survey will be available in Spring 2023. Conclusions: Acute FI is prevalent and devastating for cancer patients, although few resources exist within cancer centers to adequately address it. Legacy of Hope fills this gap through a novel program that leverages sustainable and trusted partnerships with local food distributors, civic organizations, and oncology social work teams at cancer centers throughout the Greater Philadelphia region.